Opioid-sparing pain plan after anterior total hip replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind phase 3 trial enrolls adults undergoing anterior total hip arthroplasty for osteoarthritis who will receive a standardized multimodal non-opioid analgesic regimen and counseling from a Life Care Specialist. At discharge participants are randomized to receive either a standard opioid prescription or placebo tablets, with a limited supply of rescue hydromorphone available for severe breakthrough pain. Pain scores, nausea, opioid consumption, and patient-reported outcomes are collected during the first postoperative week and at follow-up visits at 3 weeks and 3 months. The study is designed to determine whether limiting routine opioid prescriptions after hip arthroplasty can safely reduce opioid exposure without compromising recovery or patient satisfaction.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of hip osteoarthritis requiring primary arthroplasty
* Scheduled to undergo anterior total hip arthroplasty (THA)
* Able to comply with study procedures and follow-up visits
* Able to provide informed consent

Exclusion Criteria:

* Concurrent significant injuries to other bones or organs
* Local infection at or near the surgical site
* Preoperative opioid use within 4 weeks prior to surgery
* History of severe heart disease (NYHA Class II or higher), renal failure, or liver dysfunction
* Chronic liver disease
* Neurological or psychiatric conditions that may influence pain perception
* Pregnancy
* History of alcohol or medication abuse
* Inability to take NSAIDs
* Use of postoperative DVT prophylaxis other than aspirin 81 mg twice daily
* Diabetes mellitus with HbA1c \> 8.0%
* Diagnosis of chronic pain syndrome or fibromyalgia
* Pain Catastrophizing Scale (PCS) score \> 29
* Any condition that, in the investigator's judgment, may interfere with adherence to study procedures or follow-up

Where it's running

• Emory University Orthopedics and Spine Hospital
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Ajay Premkumar, MD — Emory University
• Study coordinator: Ajay Premkumar, MD
• Email: ajay.premkumar@emory.edu
• Phone: 404-778-3350

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.